drugset / Trial / NCT04692051
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Phase 2
Unknown
100 enrolled
Huazhong University of Science and Technology
CSPC Ouyi Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2021-03-01
- Completion
- 2021-09-01
Outcome
Met primary endpoint
paper p = 0.0034, hazard ratio [HR] = 0.5136, 95%CI: 0.3136-0.8411). PMID 40819029 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |